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Therapy Disc 1 (TD1)
Therapy Disc 2 (TD2)
Indications for Use: The Nalu™ Neurostimulation System is used to help manage chronic pain of the trunk and/or limbs in adults. As with all medical procedures, there are risks associated with the implantation procedure and with the use of the device. The risks associated with implantation and use of the system include, but are not limited to, pain at the implant site, infection, bleeding, nerve injury, movement or damage to the implanted components, changes in stimulation sensation, device malfunction, and the need for additional medical procedures.
In rare cases, serious complications such as paralysis, stroke, or death may occur. The system may be affected by electromagnetic interference from certain equipment or environments. Strong electromagnetic sources may cause heating of the implanted device, interruption or changes in stimulation, or uncomfortable or unexpected sensations. Do not use the Nalu Neurostimulation System if you have other implanted active medical devices, such as pacemakers or other neurostimulators, as interference may occur. Do not operate vehicles, machinery, or heavy equipment while stimulation is active, as sudden changes in stimulation may impair control and increase the risk of injury. Special care may be required after implantation of the Nalu Neurostimulation System, including following activity restrictions, avoiding excessive bending, twisting, or stretching, and carefully following your healthcare provider’s instructions. Some implanted components of the system are MR Conditional, while external components are MR Unsafe. Certain conditions must be met to safely undergo an MRI. Always inform your healthcare provider that you have an implanted neurostimulation system before undergoing any medical imaging or procedures.
You should not use this system if you are pregnant, unable to operate the device, did not experience sufficient pain relief during the trial period, or are not a suitable candidate for surgery.
Be sure to talk with your doctor so that you fully understand the potential risks and benefits associated with use of the device.
Please review the full Instructions for Use for complete details regarding indications, warnings, precautions, and potential adverse events. To report a serious incident or obtain additional information, contact Nalu Medical at +1-800-618-3402 or visit www.nalumed.com.
Caution: Federal law restricts this device to sale by or on the order of a physician